TGA issues new Australian Complementary Medicine Guidelines
Previously we wrote about the TGA planning to revise the complementary medicine guidelines. On the 13 October 2016 the Australian TGA released the sixth version of the Australian regulatory guidelines for complementary medicines ARGCM, Version 6.0, October 2016 this is is the fifth update of the Australian Complementary Medicine Guidelines since 2013. This is
This short blog is to draw your attention to the updated guidance and discuss key updates in the guidance. Based on the document history the follow key changes were made, these were –
- Update information referring to ingredients permitted in listed medicines to reflect changes in legislation (26 BB legislative instrument).
- Update references to TGO 69 to include information on new labelling order (TGO 92).
- Update information on Approved terminology for medicines.
- Update information on National Code of Conduct for unregistered healthcare practitioners.
- Update information on homoeopathic medicines.
- Review information on consent to supply goods that are not compliant with prescribed standards.
- Update guidance on changes to registered medicines, including updated ode tables.
We looked for changes in the document to a few of the older version published over the years and would like to draw your attention to a few changes or aspects customers commonly miss:
- Please read the all TGO, not only the new labelling order,
- Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 (11 October 2016)
- We often find international clients miss this old TGO Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules (29/10/2008)
- If an ingredient that is subject to any restriction or is required to be declared cannot be considered as an incidental minor excipient.
The standards recognised under the Therapeutic Goods Act 1989 (the Act) are those made by the Minister under Section 10 of the Act (Therapeutic Goods Orders) and the default standards, which currently are relevant statements in monographs in any of the following: British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.) or the United States Pharmacopeia – National Formulary(USP). It should be noted that any matter specified in an order under section 10 of the Act has precedence over requirements of the default standards. The general monographs of the BP, Ph. Eur. and USP are also relevant, for example: the BP monographs ‘Herbal Drugs’, ‘Herbal Drug Preparations’ and ‘Extracts’. The most recent edition of the cited pharmacopoeia should be used.
A very useful tool is on the TGA website is the Food-Medicine Interface Guidance Tool (FMIGT) to determine if you product is a food or therapeutic good.